(25 days)
Not Found
No
The summary describes a standard MRI system with features focused on hardware capabilities (magnet strength, channels, bore size) and image acquisition techniques (pulse sequences, reconstruction algorithms, multi-drive RF transmit). There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities beyond standard image processing. The performance studies focus on compliance with standards and system verification, not on the performance of an AI/ML algorithm.
No.
The device is indicated for use as a diagnostic imaging device to produce images and/or spectra that, when interpreted by a trained physician, may assist in diagnosis. It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic imaging device," and mentions that the images and/or spectra "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly details hardware components such as a superconducting magnet, RF receiver, and gradient systems, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SIGNA Pioneer Function: The SIGNA Pioneer is a magnetic resonance scanner. It produces images of the internal structures and functions of the entire body by using magnetic fields and radiofrequency pulses. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "diagnostic imaging device" to produce images and spectra of the body.
- Device Description: The description details the physical components and how it interacts with the body to create images, not how it analyzes biological samples.
The SIGNA Pioneer is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes
LNH
Device Description
The SIGNA Pioneer features a 3.0T superconducting magnet with a 70cm bore size
The RF receiver is equipped with up to 97 RF channels.
The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance.
The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.
The SIGNA Pioneer uses multi-drive RF transmit for imaging of the head and body regions.
The SIGNA Pioneer is designed to conform to NEMA DICOM standards.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Clinical Tests:
The subject of this premarket submission, SIGNA Pioneer, did not require clinical studies to support substantial equivalence.
Scanning of human subjects on the SIGNA Pioneer system has been conducted at GE Healthcare facilities as part of design validation activities in order to ensure that the modified device meets user requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SIGNA Pioneer (K143345)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of human profiles facing to the right, with three distinct head shapes stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 29, 2016
GE Healthcare % Mr. Glen Sabin Regulatory Affairs Director 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K160621
Trade/Device Name: SIGNA Pioneer Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: March 3, 2016 Received: March 4, 2016
Dear Mr. Sabin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SIGNA Pioneer
Indications for Use (Describe)
The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA Pioneer reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) Summary
SIGNA Pioneer
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 25, 2016 |
|---|---|
| Submitter: | GE Healthcare, (GE Healthcare Japan Corporation) |
| 7-127, Asahigaoka 4-chome, Hino-shi, | |
| Tokyo 191-8503 JAPAN | |
| Primary Contact Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-521-6848 | |
| Secondary Contact | |
| Person: | Steve Kachelmeyer |
| Senior Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-548-2432 | |
| Device Trade Name: | SIGNA Pioneer |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 |
| Product Code: | LNH |
| Predicate Device: | SIGNA Pioneer (K143345) |
| Device Description: | The SIGNA Pioneer features a 3.0T superconducting magnet |
| with a 70cm bore size |
The RF receiver is equipped with up to 97 RF channels.
The system uses a combination of time-varying magnetic
fields (gradients) and RF transmissions to obtain information
regarding the density and position of nuclei exhibiting
magnetic resonance.
The system can image in the sagittal, coronal, axial, oblique,
and double oblique planes, using various pulse sequences and
reconstruction algorithms.
The SIGNA Pioneer uses multi-drive RF transmit for imaging
of the head and body regions.
The SIGNA Pioneer is designed to conform to NEMA
DICOM standards. |
| Intended Use: | The SIGNA Pioneer is a whole body magnetic resonance
scanner designed to support high resolution, high signal-to-
noise ratio, and short scan times.
It is indicated for use as a diagnostic imaging device to
produce axial, sagittal, coronal, and oblique images,
spectroscopic images, parametric maps, and/or spectra,
dynamic images of the structures and/or functions of the entire
body, including, but not limited to, head, neck, TMJ, spine,
breast, heart, abdomen, pelvis, joints, prostate, blood vessels,
and musculoskeletal regions of the body.
Depending on the region of interest being imaged, contrast
agents may be used.
The images produced by the SIGNA Pioneer reflect the spatial
distribution or molecular environment of nuclei exhibiting
magnetic resonance. These images and/or spectra when
interpreted by a trained physician yield information that may
assist in diagnosis. |
| Technology: | The SIGNA Pioneer employs the same fundamental scientific
technology as its predicate device.
The SIGNA Pioneer system has been modified by the
introduction of a new 65 receive channel configuration, in
addition to the previously cleared 97 channel configuration.
The modified SIGNA Pioneer system also includes
enhancements to the software that controls Specific
Absorption Rate (SAR). |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests: |
| | Like the predicate device, the SIGNA Pioneer complies with
the following voluntary standards:
IEC 60601-1 IEC 60601-1-2 IEC 60601-2-33 ISO 10993-1 |
| | In addition, the SIGNA Pioneer complies with the applicable
NEMA MS standards for MRI and NEMA PS3 standard for
DICOM, as does the predicate device. |
| | The following quality assurance measures were applied to the
development of the system, as they were for the predicate: Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) |
| | Summary of Clinical Tests: |
| | The subject of this premarket submission, SIGNA Pioneer, did
not require clinical studies to support substantial equivalence. |
| | Scanning of human subjects on the SIGNA Pioneer system has
been conducted at GE Healthcare facilities as part of design
validation activities in order to ensure that the modified device
meets user requirements. |
| Conclusion: | The Indications for Use of the SIGNA Pioneer are identical to
the predicate device. The modifications to the SIGNA Pioneer
system do not change the fundamental scientific technology of
the device. The results of design controls activities
demonstrate that the SIGNA Pioneer is substantially
equivalent to the predicate with regards to safety and efficacy.
GE Healthcare considers the SIGNA Pioneer to be as safe, as
effective, and performance is substantially equivalent to the
predicate device. |
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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has a white border and a swirling design around the letters, giving it a dynamic and recognizable appearance.